Unique Device Identification (UDI) and Regulations (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics

The Medical Devices Coordination Group (MDCG) has published a number of guidance documents on the topic of UDI over the past months. More recently, the MDCG issued guiding principles for issuing entities, in which it was specified that the maximum number of characters in the Basic UDI-DI will be limited to 25.

Moreover, the MDCG announced that a decision has been made with regards to the nomenclature system to be used in EUDAMED: Economic Operators will have to use the Italian CND nomenclature, which will be mapped to the GMDN nomenclature. 

Finally, the European Commission adopted an implementing act assigning the issuing entities under the Regulations. Manufacturers may choose to work with GS1 AISBL, Health Industry Business Communications Council (HIBCC), ICCBBA or Informationsstelle für Arzneispezialitäten (IFA GmbH).

Should you require more details, please don’t hesitate to get in touch.

Sources: MDCG guidance

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